Janssen submits MAA to EMA for esketamine nasal spray

Johnson & Johnson’s Janssen Pharmaceutical Companies has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its esketamine nasal spray.

The spray is a glutamate receptor modulator indicated for treatment-resistant depression (TRD) in adults with Major Depressive Disorder (MDD) who have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode.

It serves as a rapidly acting antidepressant that might help restore synaptic connections in brain cells in patients suffering from TRD.

As an investigational product for the treatment of TRD, the nasal spray works differently than currently available therapies for depression.

Janssen Research and Development global head Dr Mathai Mammen said: "Major Depressive Disorder affects approximately 40 million people across Europe, and is the leading cause of disability worldwide.

"Of these people, about one-third does not respond to currently available treatments. Janssen is committed to improving the outcomes for patients with treatment-resistant depression, and we look forward to working with the EMA to provide a new targeted treatment option for these patients."

The EMA authorisation application is based on five pivotal Phase III studies of the esketamine nasal spray in patients with TRD.

The studies involved three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety evaluation.

In September this year, Janssen submitted a new drug application (NDA) for esketamine for TRD treatment to the US Food and Drug Administration (FDA).

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